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The Pharmacy Quality Assurance Commission previously sent out its Statement on Compounding Semaglutide and GLP-1s. The Food and Drug Administration (FDA) continues to provide guidance on this matter.
Drug products compounded for patient administration cannot use components labeled as “Research use Only” or “Not for Human Consumption”, including research peptides. Compounders should verify that any component of a compounded drug product complies with state law, such as the applicable chapter of USP, and federal law, such as the Federal Food, Drug, and Cosmetic Act (FD&C Act).
As a reminder, the FDA states biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.
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